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A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme

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Disease Information

Descriptive Information
Brief Title † A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme
Official Title † A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa™) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme
Brief Summary The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Objective tumour response at 6 months after the end of combination treatment by computerized tomography scan or magnetic resonance imaging of the brain according to Macdonald criteria.
Secondary Outcome Measure † Disease control rate at 6 months after the combination treatment, clinical or radiological progression-free-survival, overall survival and safety of ZD1839 in combination with radiotherapy.
Condition † Glioblastoma
Intervention † DrugGefitinib
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 36
Start Date † February 2003
Completion Date March 2006
Primary Completion Date
Eligibility Criteria † Inclusion Criteria: - Signed informed consent - histologically-or cytologically-confirmed glioblastoma multiforme - age 18 years or older Exclusion Criteria: - Have had prior radiation therapy, immunotherapy, gene therapy and/or chemotherapy for the glioblastoma - co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ - known severe hypersensitivity to ZD1839 or any of the excipients of this product.
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Sweden
Administrative Information
NCT ID † NCT00238797
Organization ID 1839IL/0088
Secondary IDs †† D7913L00088
Responsible Party
Study Sponsor † AstraZeneca
Collaborators ††
Investigators † Study Director: AstraZeneca Medical Science Director, MD, AstraZeneca
Information Provided By
Verification Date January 2011
First Received Date † October 12, 2005
Last Updated Date January 20, 2011
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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